Register for the onference HERE BEBPA Annual …Poster Titles Hotel International Prague Prague,...
3
Pre-Conference Workshops, September 25, 2019 Hotel Internaonal Prague Prague, Czechia Register for the Conference HERE BEBPA’s 12 th Annual EUR Bioassay Conference Best Pracces for the Best Potency Assays September 25-27, 2019 3 Ways to Register: Online at BEBPA.org – Phone: 206-651-4542 – Email: [email protected] Day 1, September 26, 2019 Session 1: Bioassay Lifecycles Session Chair: Laureen Lile, BEBPA 8:30 Welcome and Opening Comments by Laureen Lile 8:40 The Life Cycle of a Potency Method: How Lessons Learned on the Road from Assay Development Towards Commercial Validaon Lead to a High-Quality Bioassay Femke de Keijzer-van de Water, Scienst Analycal Development, Janssen Vaccines & Prevenon B.V. Session 2: Hot Topics: Ready-to-Use Cells 9:10 Audience Survey: About RTU Cells 9:15 Turning Cells into Reagents Oliver Wehmeier, Managing Director, acCELLerate GmbH 9:45 How to Select and Opmize Characterizaon Criteria for Assay-Ready Cells – A Case Study Karin Blume, Scienst, Svar Life Sciences 10:15 - 10:45 Morning Break Session 3: Assessing Similarity Session Chair: Perceval Sondag, MSD 10:45 Audience Survey: About Assessing Similarity 10:50 A Comprehensive Re-Examinaon of Equivalence Methods for Similarity David Lansky, President, Precision Bioassay, Inc 11:20 Evaluaon of a Novel Approach to Similarity Assessment in Surface Plasmon Resonance Spectroscopy Stefan Winkler, Associate Scienst, Roche Pharmaceucals AG 11:50 Your Stascian is Your Friend: Parallelism in Immunoassays Nancy Niemuth, Research Leader, Baelle 12:20- 1:40 Lunch Session 4: Bridges Over Troubled Water Session Chair: Hans-Joachim Wallny, Novars 1:45 Poster Authors Introducons by Jane Robinson 2:00 Audience Survey: About Bridges Over Troubled Water 2:05 Bridging Bioassay Methods … A Rough Sea to Cross!? Annemie Wielant, Senior Scienst, UCB Pharma 2:35 A Bioassay Comparability Assessment Between Two Contract Labs (Case Study) Anton Stetsenko, Associate Director, ADC Therapeucs 3:05 Bridging Study of ADCC Reporter Bioassay for Product Lot Release with Improved PBMC-Based ADCC Cytotoxicity Assay during Monoclonal Anbody Development Mei Cong, Director, Promega 3:35 - 4:00 Aſternoon Break Session 5: Vaccine Product Bioassays Session Chair: Krisn Clement, Bio-Val Consulng 4:00 Audience Survey: About Vaccine Product Bioassays 4:05 Developing Robust Ligand-Binding Assays Through Key Angen Characterizaon Luc Gagnon, Chief Scienfic Officer, NEOMED-Labs 4:35 Vaccine Clinical Serologies: Making the Bridge Between Analycal and Clinical Biases Anne Benoit, Expert Biostascian, GSK Vaccine 5:05 A Single Immunogenicity Assay for Tesng Angen Potency in Combinaon DTaP Vaccines: Simultaneous Quantaon of An-DT, an-TT, An-PTxd and An-FHA Anbodies in Guinea-Pig Serum with a Luminex®-xMAP® Bead-Based Serological Assay Silvio Bandiera, Senior Scienst, Sanofi Pasteur 5:35 Development of an ELISA for Use in Retrospecve Studies Using Dried Blood Spot Cards Hannah Cuthbertson, Scienst, PHE Track 1: Reference Standard – Challenges and Opportunies Instructors: Jane Robinson, Consultant, BEBPA; Bassam Hallis, Head, Public Health England; and Sian Estdale, Head, Covance; Peter Rigsby, Head of Biostascs, NIBSC Day 2, September 27, 2019 Session 6: Product Specific Case Studies Session Chair: Sian Estdale, Covance 8:30 Welcome to the Conference and Audience Survey 8:40 Smart Bioassays Development, Validaon and Transfer Eric Rozet, Director Stascs, Pharmalex Belgium 9:10 Development of a Suite of Assays to Characterize an Immuno- Oncology Target Lisa Blackwood, Senior Scienst, Sartorius Stedim Biotech 9:40 Development of a Cell-Based Bioassay for a Mixture of Two HexaBody Molecules Targeng DR5 Simone De Haij, Assistant Director, Genmab 10:10 - 10:40 Morning Break Session 7: Calculang Potency Session Chair: Mike Merges, EBSI 10: 40 Audience Survey: About Calculang Potency 10:45 What Does it Take to Calculate Potency and Which Data Do You Need? Ásdís Pétursdór, Research Scienst, Novo Nordisk 11:15 Experience with a Novel Stascal Approach to Plate Based Methods Alka Bishop, Head of Analycal, Porton BioPharma Ltd; and Sarah Was, Senior Fermentaon Development Scienst, Porton Biopharma Ltd Session 8: Professor David J. Finney Tribute Session Chair: Mike Merges, EBSI 11:45 To Finney and Beyond Ann Yellowlees, Director, Quancs Biostascs 12:05 Drawing for Professor Finney Book, Drawing for The 4PL, Svar Prize Drawing. 12:20- 1:30 Lunch Session 9: Potency Assays for Complex Products: Gene Therapy and Cell- Based Products Session Chair: Roger Grau, NBE/Biosimilar 1:30 Audience Survey: About Potency Assays for Complex Products 1:35 Passport to BEBPA Prize Drawing 1:40 Quality Control for Cell and Gene Therapy Products: Case Study of an Autologous CAR T Cell Product Petra Schroeder, Head of Cell and Gene Therapy, BioNTech IMFS GmbH 2:10 Delivering the Message Barbara Hebeis, Associate Director, AstraZeneca 2:40 Potency Assessment for Novel AAV-Based Drugs: Exploraon of Different Biological Acvies and Stability Indicang Properes of the Assays Marina Feschenko, Principal Scienst, Biogen 3:10 - 3:35 Aſternoon Break Session 10: Bioassays for Product Characterizaon Session Chair: Bassam Hallis, Public Health England 3:35 Audience Survey: About Bioassays for Product Characterizaon 3:40 Bench to Bedside: Efpeglenade Bioassays Stuart Dunn, Senior Manager, Bioassay Development, Covance; and Chrisne Graf, Associate Scienst, Sanofi 4:10 Novel Cell-Based Assays to Enable Immunotherapy Drug Development for Checkpoint Receptors Jane Lamerdin, Director, Eurofins DiscoverX 4:40 Bioanalycal Characterizaon of a Highly Acve TP Natko Nuber, Analycal Project Lead/ Group Head, Novars Pharma AG 5:10 Conference Adjourns 3:30-5:30PM (Open to all Workshop aendees) Track 3: The USP Bioassay Chapters: Come Join the Journey Instructor: Steven Walfish, Principal Scienfic Liaison, United States Pharmacopia Workshops Track 2: Introducon to Stascs for Assay Validaon Instructor: Perceval Sondag, Associate Principal Stascian, MSD 9:00AM — 3:00PM
Transcript of Register for the onference HERE BEBPA Annual …Poster Titles Hotel International Prague Prague,...
Pre-Conference Workshops, September 25, 2019
Hotel International Prague Prague, Czechia
Register for the Conference HERE BEBPA’s 12th Annual
EUR Bioassay Conference Best Practices for the Best Potency Assays
September 25-27, 2019
3 Ways to Register: Online at BEBPA.org – Phone: 206-651-4542 – Email: [email protected]
Day 1, September 26, 2019 Session 1: Bioassay Lifecycles
Session Chair: Laureen Little, BEBPA
8:30 Welcome and Opening Comments by Laureen Little
8:40 The Life Cycle of a Potency Method: How Lessons Learned on the Road from Assay Development Towards Commercial Validation Lead to a High-Quality Bioassay
Femke de Keijzer-van de Water, Scientist Analytical Development, Janssen Vaccines & Prevention B.V.
Session 2: Hot Topics: Ready-to-Use Cells
9:10 Audience Survey: About RTU Cells
9:15 Turning Cells into Reagents Oliver Wehmeier, Managing Director, acCELLerate GmbH
9:45 How to Select and Optimize Characterization Criteria for Assay-Ready Cells – A Case Study Karin Blume, Scientist, Svar Life Sciences
10:15 - 10:45 Morning Break
Session 3: Assessing Similarity
Session Chair: Perceval Sondag, MSD
10:45 Audience Survey: About Assessing Similarity
10:50 A Comprehensive Re-Examination of Equivalence Methods for Similarity
David Lansky, President, Precision Bioassay, Inc
11:20 Evaluation of a Novel Approach to Similarity Assessment in Surface Plasmon Resonance Spectroscopy
Stefan Winkler, Associate Scientist, Roche Pharmaceuticals AG
11:50 Your Statistician is Your Friend: Parallelism in Immunoassays Nancy Niemuth, Research Leader, Battelle
12:20- 1:40 Lunch
Session 4: Bridges Over Troubled Water
Session Chair: Hans-Joachim Wallny, Novartis
1:45 Poster Authors Introductions by Jane Robinson
2:00 Audience Survey: About Bridges Over Troubled Water
2:05 Bridging Bioassay Methods … A Rough Sea to Cross!? Annemie Wielant, Senior Scientist, UCB Pharma
2:35 A Bioassay Comparability Assessment Between Two Contract Labs (Case Study) Anton Stetsenko, Associate Director, ADC Therapeutics
3:05 Bridging Study of ADCC Reporter Bioassay for Product Lot Release with Improved PBMC-Based ADCC Cytotoxicity Assay during Monoclonal Antibody Development
Mei Cong, Director, Promega
3:35 - 4:00 Afternoon Break
Session 5: Vaccine Product Bioassays
Session Chair: Kristin Clement, Bio-Val Consulting
4:00 Audience Survey: About Vaccine Product Bioassays
4:05 Developing Robust Ligand-Binding Assays Through Key Antigen Characterization
Luc Gagnon, Chief Scientific Officer, NEOMED-Labs
4:35 Vaccine Clinical Serologies: Making the Bridge Between Analytical and Clinical Biases
Anne Benoit, Expert Biostatistician, GSK Vaccine
5:05 A Single Immunogenicity Assay for Testing Antigen Potency in Combination DTaP Vaccines: Simultaneous Quantitation of Anti-DT, anti-TT, Anti-PTxd and Anti-FHA Antibodies in Guinea-Pig Serum with a Luminex®-xMAP® Bead-Based Serological Assay
Silvio Bandiera, Senior Scientist, Sanofi Pasteur
5:35 Development of an ELISA for Use in Retrospective Studies Using Dried Blood Spot Cards
Hannah Cuthbertson, Scientist, PHE
Track 1: Reference Standard – Challenges and Opportunities Instructors: Jane Robinson, Consultant, BEBPA; Bassam Hallis, Head, Public Health England; and Sian Estdale, Head, Covance; Peter Rigsby, Head of Biostatistics, NIBSC
Day 2, September 27, 2019 Session 6: Product Specific Case Studies
Session Chair: Sian Estdale, Covance
8:30 Welcome to the Conference and Audience Survey
8:40 Smart Bioassays Development, Validation and Transfer Eric Rozet, Director Statistics, Pharmalex Belgium
9:10 Development of a Suite of Assays to Characterize an Immuno-Oncology Target
Lisa Blackwood, Senior Scientist, Sartorius Stedim Biotech
9:40 Development of a Cell-Based Bioassay for a Mixture of Two HexaBody Molecules Targeting DR5
Simone De Haij, Assistant Director, Genmab
10:10 - 10:40 Morning Break
Session 7: Calculating Potency
Session Chair: Mike Merges, EBSI
10: 40 Audience Survey: About Calculating Potency
10:45 What Does it Take to Calculate Potency and Which Data Do You Need?
Ásdís Pétursdóttir, Research Scientist, Novo Nordisk
11:15 Experience with a Novel Statistical Approach to Plate Based Methods
Alka Bishop, Head of Analytical, Porton BioPharma Ltd; and Sarah Watts, Senior Fermentation Development Scientist, Porton Biopharma Ltd
Session 8: Professor David J. Finney Tribute Session Chair: Mike Merges, EBSI 11:45 To Finney and Beyond Ann Yellowlees, Director, Quantics Biostatistics
12:05 Drawing for Professor Finney Book, Drawing for The 4PL, Svar Prize Drawing.
12:20- 1:30 Lunch
Session 9: Potency Assays for Complex Products: Gene Therapy and Cell-
Based Products
Session Chair: Roger Grau, NBE/Biosimilar
1:30 Audience Survey: About Potency Assays for Complex Products 1:35 Passport to BEBPA Prize Drawing 1:40 Quality Control for Cell and Gene Therapy Products: Case Study of an
Autologous CAR T Cell Product Petra Schroeder, Head of Cell and Gene Therapy, BioNTech IMFS GmbH 2:10 Delivering the Message Barbara Hebeis, Associate Director, AstraZeneca
2:40 Potency Assessment for Novel AAV-Based Drugs: Exploration of Different Biological Activities and Stability Indicating Properties of the Assays
Marina Feschenko, Principal Scientist, Biogen
3:10 - 3:35 Afternoon Break
Session 10: Bioassays for Product Characterization
Session Chair: Bassam Hallis, Public Health England
3:35 Audience Survey: About Bioassays for Product Characterization
3:40 Bench to Bedside: Efpeglenatide Bioassays Stuart Dunn, Senior Manager, Bioassay Development, Covance; and Christine Graf, Associate Scientist, Sanofi
4:10 Novel Cell-Based Assays to Enable Immunotherapy Drug Development for Checkpoint Receptors
Jane Lamerdin, Director, Eurofins DiscoverX
4:40 Bioanalytical Characterization of a Highly Active TP Natko Nuber, Analytical Project Lead/ Group Head, Novartis Pharma AG
5:10 Conference Adjourns
3:30-5:30PM (Open to all Workshop attendees) Track 3: The USP Bioassay Chapters: Come Join the Journey Instructor: Steven Walfish, Principal Scientific Liaison, United States Pharmacopia
Workshops Track 2: Introduction to Statistics for Assay Validation Instructor: Perceval Sondag, Associate Principal Statistician, MSD
9:00AM — 3:00PM
Poster Titles
Hotel International Prague Prague, Czechia
Register for the Conference HERE BEBPA’s 12th Annual
EUR Bioassay Conference Best Practices for the Best Potency Assays
September 25-27, 2019
3 Ways to Register: Online at BEBPA.org – Phone: 206-651-4542 – Email: [email protected]
Poster Title Author Company
Development of a Suite of Assays to Characterize Omalizumab Debbie Allan Sartorius Stedim Biotech
Evaluation of iLite ADCC Effector Cells Using Different CD20 Target Cells Karin Blume Svar Life Science AB
Parallelism Assessment in Bioassay from Development to Transfer Claire Borel Sanofi
Automation of ELISA Platform by Liquid Handling Station Accelerates Analysis of
Therapeutic Antibodies Anke Breckner AbbVie Deutschland GmbH & Co.KG
SPR For Tomorrow’s Biotherapeutics Jennifer Clark Antibody Analytics
Bridging MOA-based ADCC Reporter Bioassay with an Improved PBMC-based ADCC
Cytotoxicity Assay for Immunotherapy mAb Development Mei Cong Promega Corporation
Fixed and Random Effects in Non-Linear Models for ELISA Assay Calibration Lorraine Dawirs GSK
T-Cell Redirecting Antibodies Based Bioassay for Evaluation of PD-1/PD-L1 Inhibitors
Activity Alexander Doronin BIOCAD
T-cell Exhaustion: An in vitro Model that Emulates a Complex Biological Phenomenon Lynne Dunsford Antibody Analytics
Quantitative Cell-Based Bioassays to Advance Immunotherapy Programs Targeting
Immune Checkpoint Receptors Steven Edenson Promega Corporation
Case Study: Different Estimators of Precision and Measures for the Goodness-of-Fit in
a Cell-Based Potency Assay Nicole Herzmann
Richter-Helm BioLogics GmbH & Co.
KG
Novel Reporter-based Bioassays for Evaluating FcγR-dependent Functions of
Therapeutic Antibodies Axel Johann Promega GmbH
Assessing the Potency of SPEAR T-Cells: Development and Validation of a Flow
Cytometry-Based Cytotoxicity Assay Rachel Kenneil Adaptimmune
Novel, Improved Cell-Based Assays to Enable Immunotherapy Drug Development for
Checkpoint Receptors Jane Lamerdin Eurofins DiscoverX
Qualified, Fit-for-Purpose Bioassays for Liraglutide and Exenatide as Frozen Ready-to-
Use Cells Jane Lamerdin Eurofins DiscoverX
Building Robust and Simple Cell-Based Assays for Interleukins and Their Receptors Jane Lamerdin Eurofins DiscoverX
Cell-Based Acoustic Liquid Handling Paula Urquhart Covance Laboratories
Thank You to Our 2019 Sponsors
Hotel International Prague Prague, Czechia
Register for the Conference HERE BEBPA’s 12th Annual
EUR Bioassay Conference Best Practices for the Best Potency Assays
September 25-27, 2019
3 Ways to Register: Online at BEBPA.org – Phone: 206-651-4542 – Email: [email protected]
